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The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level 100 mg t.i.d.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom control change from baseline to week 39 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 39 in activities of daily living | ||
| Change from baseline to week 39 in motor function | ||
| Change from baseline to week 39 in mental acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center | Phoenix | Arizona | 85013 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19058133 | Derived | Hauser RA, Panisset M, Abbruzzese G, Mancione L, Dronamraju N, Kakarieka A; FIRST-STEP Study Group. Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease. Mov Disord. 2009 Mar 15;24(4):541-50. doi: 10.1002/mds.22343. |
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| Change from baseline to week 39 in incidence of dyskinesia and wearing off |
| Coastal Neurological Medical Group, Inc |
| La Jolla |
| California |
| 92037 |
| United States |
| Neurosearch, Inc. | Reseda | California | 91335 | United States |
| University of Florida Health Science Center | Jacksonville | Florida | 32209 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| USF Medical Clinic | Tampa | Florida | 33612 | United States |
| Springfield Neurology Associates, LLC | Springfield | Massachusetts | 01104 | United States |
| Clinical Neuroscience Center | Southfield | Michigan | 48034 | United States |
| Melbourne Internal Medicine Associates | Westlake | Ohio | 44145 | United States |
| Westmoreland Neurology Associates, Inc. | Greensburg | Pennsylvania | 15601 | United States |
| Lankenau Hospital | Wynnewood | Pennsylvania | 19096-3425 | United States |
| NeuroHealth | Warwick | Rhode Island | 02886 | United States |
| Coastal Neurology, PA | Beaufort | South Carolina | 29902 | United States |
| Senior Adults Specialty Research | Austin | Texas | 78757 | United States |
| Baylor College of Medicine, Parkinson's Disease Center | Houston | Texas | 77030 | United States |
| Neurology Associates | San Marcos | Texas | 78666 | United States |
| Blue Ridge Research Center at Roanoke Neurological Center | Roanoke | Virginia | 24014 | United States |
| Heritage Medical Research Clinic | Calgary | Alberta | T2N 4N1 | Canada |
| Moncton | New Brunswick | E1C 2M4 | Canada |
| Eastern Health Care - Health Sciences Centre, Neurology Department | HSC Room 5317, 300 Prince Philip Drive, Saint John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Neurology Division, Health Science Center | Halifax | Nova Scotia | B3J 3T1 | Canada |
| Cape Breton Regional Hospital, Neurology Department | Sydney | Nova Scotia | B1P 1P3 | Canada |
| Grand River Hospital | Kitchener | Ontario | N2H 5Z8 | Canada |
| London Health Sciences Center, University Hospital, Rm. A10-026 | London | Ontario | N6A 5A5 | Canada |
| Centre for Movement Disorders | Markham | Ontario | L6B 1C9 | Canada |
| Parkinson's & Neurodegenerative Disorders Clinic | Ottawa | Ontario | K1G 4G3 | Canada |
| Ottawa Hospital, Civic Campus | Ottawa | Ontario | K1Y 4E9 | Canada |
| Hiren Desai Medicine Professional Corporation | Windsor | Ontario | N8X 5A6 | Canada |
| Neuro Rive Sud | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Montreal General Hospital | Montreal | Quebec | H3G 1A4 | Canada |
| Unite des Troubles du Mouvement Andre-Barbeau, CHUM-Hotel-Dieu | Montreal | Quebec | Canada |
| Centre de Recjerche Clinique du CHUS | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Dr. Felix Veloso Research | Regina | Saskatchewan | S4T 1A5 | Canada |
| Quebec Memory and Motor Skills Disorders Clinic | Québec | G1R 3X5 | Canada |
| University of Saskatchewan, Royal University Hospital | Saskatoon | S7N 0W8 | Canada |
| Neurologická klinika, Univerzita Palackého | I.P.Pavlova 6 | Olomouc | 775 20 | Czechia |
| FN-neurologická klinika | Alej Svobody 80 | Plzeň | 304 60 | Czechia |
| Neurologicka klinika | Katerinska 12, Praha 2 | 12000 | Czechia |
| FN-Nemocnice Pardubice | Kyjevska 44, Pardubice | 53000 | Czechia |
| Rambam Medical Center | Haliya Hashniya 8 | Haifa District | 31096 | Israel |
| Dep. Of Neurology (Bitan 38, EEG institute) | Dep. of Neurology, Zerifin | 70300 | Israel |
| Belinson Campus, Jabotinsky st. Movement Disorder Unit | Petah Tikva | 49100 | Israel |
| Sourasky Medical Center | Weitzman Saint Movement Disorder Clinic, Tel Aviv | 64239 | Israel |
| Clinica Neurologica I - Azienda Ospedaliera-Universitaria Policlinico - Università di Catania | Via Santa Sofia 78 | Catania | 95123 | Italy |
| "Dipartimento di Neuroscienze Oftalmologia e Genetica (DINOG) | Università Degli Studi Di Genova, Via de Toni 5 | Genova | 16132 | Italy |
| Unità Operativa Complessa Neurologia - Policlinico Universitario "G. Martino" | Via Consolare Valeria | Messina | 98125 | Italy |
| Istituto Nazionale Neurologico "Carlo Besta" | Via Celoria 11 | Milano | 20100 | Italy |
| Dipartimento di Neuroscienze-Sezione Neurologia Università degli Studi di Pisa- AO S. Chiara | Via Roma, 67 | Pisa | 56127 | Italy |
| Dipartimento di Scienze Neurologiche Università degli Studi di Roma "La Sapienza" Roma I | Viale dell'Università 30 | Roma | 00185 | Italy |
| Dipartimento di Neuroscienze-Università degli Studi di Torino | Via Cherasco 15 | Torino | 10126 | Italy |
| A.O. Istituti Clinici di Perfezionamento-Unita'Operativa Centro Parkinson | Via Bignami 1, Milan | 20126 | Italy |
| Samodzielny Publiczny Szpital Kliniczny Oddzial Kliniczny Neurologii i Epiletologii | Ul. Czerniakowska 231, Warszawa | 00-416 | Poland |
| Centrum Neurologii Klinicznej | Ul. Dwernickiego 8, Krakow | 31-530 | Poland |
| Klinika Neruologii Wieku Podeszlego | ul.Medykow 14, Katowice | 40-752 | Poland |
| Hospitais da Universidade de Coimbra (Serv. Neurologia) | Avenida Bissaya Barreto, Coimbra | 3000-075 | Portugal |
| Hospital de Santa Maria (Serv. Neurologia) | Avenida Professor Egas Moniz, Lisbon | 1649-035 | Portugal |
| Hospital de Santo António (Serv. Neurologia) | Largo Professor Abel Salazar, Porto | 4099-001 | Portugal |
| Istanbul CAPA Medical School | Istanbul University CAPA Medical School, Dept. of Neurology | Istanbul | 34610 | Turkey (Türkiye) |
| Hacettepe Medical School, Department of Neurology | Hacettepe Universitesi Hastaneleri Norooji AD Sihhiye, Ankara | 6,100 | Turkey (Türkiye) |
| Dokuz Eylul Medical School, Department of Neurology | Noroloji Anabilim Dali Inciralti Izmir, Izmir | 35340 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| C071192 | entacapone |
| C481098 | Stalevo |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
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